Comprehensive Evaluation of the Impact of a Short-Term Analytical Treatment Interruption and Re-Initiation of Antiretroviral Therapy on Immunologic and Virologic Parameters in HIV-Infected Individuals.
Goal of Study
The NIH is conducting a research study for people living with HIV and on HIV medications. In most people infected with HIV, their immune system is not able to control HIV infection and daily medications are needed. Combination antiretroviral therapy (cART) is a combination of anti-HIV drugs taken daily in order to keep the amount of HIV virus very low for a long time and prevent HIV infection from damaging the immune system. If cART treatment is stopped the immune system isn't able to control the infection, and HIV levels go up again. However, people who take cART can also develop resistance to the medications and may have permanent side effects.
The main purpose of this study is to gain more information on the impact of a short-term treatment stop on HIV, which persists even while taking cART. Understanding why HIV replication continues could provide an explanation of the source of the HIV persistence. When stopping treatment, the information gathered could show the study team how to develop curative treatments in the future.
A total of 30 individuals between the ages of 18-65 are expected to participate in this study. Your study participation time is expected to be about one to two years. This study consists of a Screening Visit, Baseline Visit, Study Phase, and a Follow-up Phase. At the Screening Visit tests will be done to see if you can be in the study.
If you are taking non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as efavirenz, etravirine nevirapine and rilpivirine, you will switch to a protease inhibitor (atazanavir, darunavir, ritonavir, etc.) or an integrase inhibitor-based regimen (dolutegravir, elvitegravir or raltegravir) 2 weeks before Day 0. Then you enter the Study Phase.
The Study Phase is the part of the study that your cART will be temporarily stopped. You will remain in the Study Phase part of the study until you meet the criteria to restart cART. When you restart your cART this will be the Follow-up Phase of the study and you will be followed for about 12 months. Your study visits will be at the NIH Clinical Center in Bethesda, Maryland as described below. Volunteers will be compensated.
- You are 18-65 years old and living with HIV
- You have taken HIV medications continuously for at least three years
- You have never taken fewer than three drugs in combination to suppress your HIV
- You have a CD4 (t-cell) count of 450 or more at screening
- You have had an HIV viral load that is below the limit of detection for at least three years
- Your CD4 (t-cell) count has never been <200
- You did not start HIV medications within 12 weeks of your HIV diagnosis
- You do not have hepatitis B or Hepatitis C
- You do not have heart problems
- If female, you are not breast-feeding, pregnant, or trying to become pregnant
- You agree to safer sex practices while on study
You are available for weekly clinic visits.